Towards a pathway for health products containing cannabidiol: What we heard report
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Natural health products containing cannabidiol
Context and overview of the consultation process
On March 7, 2025, we published an exploratory discussion paper to gather feedback from stakeholders and members of the public regarding the potential authorization of natural health products containing cannabidiol (NHPCCs). Authorization of NHPCCs would enable consumer access to products that are supported by adequate evidence to treat specific or minor ailments.
The discussion paper focused on 5 key elements, though feedback on other topics was also welcomed:
- site licensing, good manufacturing practices (GMP) and product quality
- packaging and labelling
- clinical trials
- advertising and promotion
- post-market safety monitoring of NHPCCs
Interested parties were invited to provide feedback between March 7 and June 5, 2025. Respondents provided comments by email as well as an online form.
We received a total of 135 submissions from stakeholders and members of the public, including:
- 15 industry associations
- 37 individual companies
- 54 healthcare practitioners
- 4 government bodies and agencies
- 4 academics
- 2 advocacy groups
- 19 individual submissions that indicated ‘other’, ‘prefer not to answer’, ‘general public’, or ‘unknown’
Key themes and stakeholder feedback
Regulatory framework and licensing
Respondents commented on the development of a pathway under the Natural Health Products Regulations(NHPR) and whether a cannabis drug licence (CDL), issued under the Cannabis Regulations, and specific physical and personnel security controls should be required for NHPCCs.
Industry associations
Most respondents agreed that a CDL should not be required for NHPCCs, noting that:
- the current licensing framework for natural health products (NHP) already ensures product quality, consumer safety and risk management. Cannabidiol, commonly known as CBD, and other non-psychoactive cannabinoids (for example: Cannabigerol (CBG), Cannabichromene (CBC), Cannabidivarin (CBDV)) should be treated like other NHP ingredients; there is no need for a separate classification or duplicate licensing under two separate regulatory regimes
- CBD is non-psychoactive, meaning it is not mind altering, and has a low potential for misuse or dependence
- additional licensing and security would increase complexity and costs and could stifle innovation and hinder market access
Some supported using the CDL, if one is already held, but not requiring it otherwise.
One respondent supported requiring a CDL when the product contains more than 0.3% tetrahydrocannabinol (THC).
Many respondents noted that:
- the security measures should be proportionate to the risk and potency of CBD products
- there is no need for extra controls at the distribution level if existing NHP regulations are followed
Individual companies
Most respondents agreed that a CDL should not be required and had mixed reactions to introducing additional security measures, noting that:
- a CDL would treat NHPCCs as pharmaceutical drugs, which they see as excessive for wellness products
- a CDL could present a barrier to innovation, adding cost, complexity and delays, potentially pushing companies toward illegal markets
- existing NHP regulations (for example: GMP, site licensing, labeling, certificates of analysis) already ensure safety and quality
- CBD is non-psychoactive, non-addictive and has a strong safety profile, especially at low doses
- other jurisdictions (for example: European Union, United States) have distinguished CBD from narcotics and removed it from controlled substance schedules
Their key points against additional security controls included that:
- security control measures would be disproportionate to risk. High-security storage, surveillance and personnel checks would be unnecessary for non-intoxicating, low-risk CBD products
- such controls would increase operational costs and limit consumer access
- data does not support an increased risk of diversion or criminal activity for CBD products
Some companies supported conditional or hybrid approaches, such as:
- requiring a CDL if the THC content exceeds 0.3%
- using the NHP framework for manufacturing and quality, but applying targeted Cannabis Act-level security for import/export and storage
- requiring a CDL and security controls for raw material suppliers, not for manufacturers or retailers
A minority of respondents supported maintaining current cannabis licensing and security standards, noting that:
- a CDL ensures Health Canada can inspect and verify manufacturing standards
- physical and personnel security controls help prevent illegal diversion of cannabis-derived materials
- clear licensing pathways can help small businesses operate legally while maintaining safety
Health care practitioners and health care associations
Most respondents, namely pharmacists, agreed that a CDL should not be required and had mixed reactions to introducing other security measures, noting that:
- CBD is non-intoxicating and has a strong safety profile, especially in low-dose formulations (for example: 20:1 or 25:1 CBD:THC ratios)
- CDL requirements are seen as excessive for non-psychoactive products and could increase operational costs, limit patient access, hinder small producers and push consumers toward illegal markets
- existing pharmacy setups are sufficient as pharmacies already follow strict standards for storage and distribution of controlled substances
- measures like surveillance, restricted access and background checks are unnecessary for low-risk CBD products
Some supported conditional or hybrid approaches. Their comments included:
- support for conditional approach where a CDL is required when a product contains more than 0.3% THC
- proposing a model where manufacturing and quality are governed by NHP regulations, and security controls from the Cannabis Act apply only to high-risk activities (for example: handling THC or raw cannabis materials)
- permitting low-THC products under existing NHP GMP standards and pharmacy-level secure storage
A minority of respondents noted that:
- a CDL and full security controls should apply to facilities that also handle THC, due to the higher risk of diversion
- they support continuing current physical and personnel security requirements for sites licensed under the Cannabis Regulations that produce CBD products
Some other recommendations on licensing and security included:
- using risk-based regulation that differentiates between intoxicating and non-intoxicating cannabis-derived ingredients
- leveraging pharmacist oversight by using existing pharmacy frameworks to ensure safe access and professional guidance
- avoiding duplicative regulation such as layering CDL requirements on top of existing NHP and pharmacy standards
Provincial governments
The one respondent on this issue was not supportive of requiring a CDL or specific physical and personnel security controls, considering the low risk of diversion of products containing CBD.
The respondent also noted that:
- they support maintaining site licensing under the NHPR for the manufacturing, packaging, labeling and importing of NHPCCs
- Health Canada should revisit the protocols and standard operating procedures under the NHPR to ensure there are adequate protections in place at the manufacturing stage
Academia
The one response received was not supportive of requiring a CDL and did not comment further on physical and personnel security controls.
The respondent also indicated support for a site licence under the NHPR for the manufacturing, packaging, labelling and importing of NHPCCs.
Individuals
Most respondents were not supportive of requiring a CDL, noting that:
- CBD is non-psychoactive, non-addictive and has a low potential for harm
- applying the same rules as high-THC cannabis is excessive and burdensome
- stricter controls could limit access, especially for small producers, and stifle innovation
Some respondents also noted that existing frameworks (for example: the Food and Drug Regulations) already govern safety and quality, and many supported a risk-based approach rather than blanket regulation.
A minority of respondents supported requiring a CDL if the product contains cannabis derivatives and emphasized maintaining industry standards and traceability for cannabis-derived ingredients.
Other comments received on licensing and security included:
- that commercial growers should require licences but not manufacturers of finished NHPCCs
- recommending implementation of hybrid models, such as requiring NHP site licence holders to source CBD from licensed cannabis processors
Advocacy organizations
No comments received.
Good manufacturing practices and quality considerations
Stakeholders commented on the need for additional raw material GMP standards or qualifications and a Certificate of Analysis (CoA) for CBD.
Industry associations
Good manufacturing practices
Most respondents were not supportive of additional GMP requirements, noting that:
- current standards, including the Good Production Practices (GPP) under the Cannabis Act, the World Health Organization Good Agricultural and Collection Practices (WHO GACP) for cultivation, and the existing GMP regime under the NHPR already govern safety, quality and traceability
- imposing pharmaceutical-style GMP would disproportionately affect small producers, increase costs and reduce product diversity without clear public health benefits
- additional GMP standards are duplicative, especially for raw CBD inputs already required to meet GPP under the Cannabis Act
Some industry associations indicated support for a dual licensing system that allows co-located cannabis and NHP manufacturing facilities to streamline operations and reduce regulatory burden. They also recommended aligning with global standards (for example: European Medicines Agency, WHO GACP, European Pharmacopoeia) and recognizing ISO 17025-traceable certificates of analysis for quality assurance from the International Organization for Standardization.
Certificate of analysis for CBD
Most respondents were supportive of requiring a CoA for CBD, noting that:
- CoAs are essential for verifying cannabinoid content (for example: CBD, THC) and ensuring product safety
- this approach aligns with international standards (for example: European Pharmacopoeia, United States Pharmacopeia, WHO) and supports consumer safety and regulatory compliance
Some other recommendations on CoA requirements included that:
- CoAs should feature results for cannabinoid profile, microbial contaminants, heavy metals, mycotoxins and pesticide residues
- qualified, accredited laboratories should conduct testing
- batch-specific CoAs should be required for finished products before market release
Individual companies
Good manufacturing practices
Most respondents were not supportive of additional GMP requirements, noting that:
- existing GPP requirements under the Cannabis Act and GMP requirements under the NHPR are sufficient
- additional GMP requirements could increase production costs, disadvantage small producers and limit market access and product diversity
- imposing new GMP layers would be duplicative, especially when current cannabis processors already meet high standards
Many respondents expressed general support for WHO GACP requirements since they are globally recognized and sufficient for the quality of raw material.
Some respondents expressed support for harmonizing GMP standards with existing NHPR GMP requirements and cautioned against creating new regulatory burden. They suggested:
- recognizing standard cannabis processing licences as equivalent to NHP site licences
- developing a CBD monograph to define quality and safety parameters
- clarifying THC content limits and testing methods
A few respondents were supportive of additional GMP requirements, noting that:
- GMP ensures product consistency, safety and consumer trust
- full-spectrum CBD products need clear THC limits and traceability
- pharmaceutical-grade standards should be applied (for example: batch consistency, third-party testing)
Certificate of analysis for CBD
Most respondents were supportive of requiring a CoA for CBD. Their comments highlighted that the purpose of a CoA is to confirm CBD potency and THC limits, verify absence of contaminants (for example: pesticides, heavy metals, solvents, microbes) and support product consistency and safety.
Many respondents expressed interest in harmonizing format and testing criteria for CoAs with existing standards, such as those established by Health Canada’s cannabis program, to streamline compliance and avoid duplication.
Some respondents recommended a CoA for both raw materials and finished products.
A few respondents noted that existing CoA requirements under the Cannabis Act are sufficient, and no additional measures are needed.
Health care practitioners and health care associations
Good manufacturing practices
Most respondents were supportive of additional GMP requirements. They noted that:
- CBD used in NHPCCs should meet the same GMP standards as other NHP ingredients to maintain public trust and ensure clinical trial eligibility
- Cannabis Act licence holders should align with NHPR standards for identity, purity, potency and safety
- harmonizing GMP requirements with the GPP requirements under the Cannabis Act would support broader acceptance in pharmacies and among healthcare providers
In addition, one respondent was supportive of GMP requirements for CBD raw materials to ensure consistency and safety.
Some respondents noted that existing GPP requirements under the Cannabis Act already govern safety and quality, and that additional GMP requirements could increase costs and limit product diversity without clear public health benefits.
Certificate of analysis for CBD
Most respondents were supportive of requiring a CoA for CBD and noted that CoAs are essential for quality assurance since they:
- verify cannabinoid content (especially THC less than 10 parts per million)
- confirm absence of contaminants (for example: microbes, heavy metals, solvents, pesticides)
- help ensure accurate labeling and consumer safety
They also recommended that CoAs should follow consistent criteria and be easily accessible (for example: via QR codes).
One respondent was supportive of mandatory CoAs to enhance transparency and consumer confidence.
Provincial governments
Good manufacturing practices
One comment was received supporting additional GMP standards for raw materials supplied by Cannabis Act licence holders. They noted that this would ensure CBD used in NHPCCs conforms with established NHP standards.
Certificate of analysis for CBD
Respondents were supportive of requiring a CoA for CBD to verify its purity, potency and absence of contaminants (including THC). The approach would help reduce and prevent long-term and short-term health risks associated with contaminated CBD products.
They highlighted that lab testing and unbiased verification of CBD content are crucial to maintain effective quality control and standards.
Academia
Good manufacturing practices
No comments received.
Certificate of analysis for CBD
Respondents were supportive of requiring a CoA for CBD to ensure quality and purity standards.
They noted that a CoA should cover critical quality attributes in terms of identity, composition and limits for contaminants, as well as the scientifically validated analytical methods to test these parameters.
Individuals
Good manufacturing practices
Most respondents were not supportive of additional GMP requirements. They noted that consistent quality standards like the ones already in place for all NHP ingredients are needed to build public trust.
Respondents also noted that:
- existing GPP requirements under the Cannabis Act already govern product safety and quality
- GMP is unnecessary unless there is clear evidence that GPP requirements are inadequate
- additional GMP requirements could increase costs, disproportionately affect small producers and reduce product diversity
- imposing pharmaceutical-grade GMP could favour large corporations and undermine smaller, compliant producers
Certificate of analysis for CBD
Most respondents were supportive of requiring a CoA for CBD, noting that a CoA:
- ensures product quality, purity and accurate labeling
- confirms absence of contaminants (for example: pesticides, heavy metals, microbes)
- verifies THC levels are within legal limits (for example: less than 10 parts per million)
Respondents also noted that CoAs help consumers make informed decisions and maintain confidence in product safety.
They suggested that Health Canada include standardized testing methods and make CoAs easily accessible (for example: via QR codes).
Advocacy organizations
No comments received.
Packaging and labelling
Respondents provided comments on the need for NHPCCs to include a warning statement about CBD on the principal display panel (often referred to as “front of pack”), as well as other label and packaging considerations.
Industry associations
Most respondents were not supportive of requiring a warning statement for CBD on the principal display panel, noting that:
- CBD is well-tolerated and non-intoxicating, and the front of pack warnings could mislead consumers or create unnecessary fear
- universal warnings for these products are seen as premature and potentially misleading
- risk communication should remain flexible and evidence-driven, adapting as new data emerges
Respondents noted that:
- existing regulations are sufficient
- the product facts table required for NHPs already includes evidence-based risk information
- Health Canada provides pre- and post-market safety oversight
- including warnings on the principal display panel may not be feasible due to space limitations and packaging sustainability concerns
Other considerations
Respondents were supportive of requiring other targeted warnings, as appropriate, and recommended that warnings should:
- be clear and concise
- highlight potential drug interactions
- be placed appropriately (not necessarily on the front panel)
- be based on evidence, not on fear
Many supported aligning NHPCC labelling with existing NHP standards, including:
- clear disclosure of CBD content as a medicinal ingredient
- cautionary statements about potential drug interactions (for example: similar to cautions about grapefruit-drug interactions) and consulting a healthcare practitioner
Some respondents recommended that Health Canada establish a labelling standard for CBD, including permitted claims and required risk statements.
Individual companies
Most respondents were not supportive of requiring a warning statement for CBD on the principal display panel, noting that:
- CBD is well-tolerated and non-intoxicating at low doses, making front of pack warnings unnecessary
- risk information is already required elsewhere on NHP labels (for example: in the warnings section of the product facts table)
- overly cautious warnings could stigmatize CBD products and mislead consumers about their safety
They recommended:
- using proportionate, evidence-based warnings without duplicating existing label requirements
- having warnings that address risks for pregnant or breastfeeding individuals, children, and those with chronic conditions
- aligning labelling of known interactions with similar statements found on other NHPs
Other considerations
Respondents were supportive of clearly labelling the amount of CBD contained in each dose and per package. They noted that labels should help consumers make informed decisions, especially those taking other medications or managing health conditions.
They also supported standardized labelling practices, including the use of:
- plain language
- pictograms for accessibility
- QR codes or websites for additional product information
Many respondents supported a warning about potential interactions with medications (for example: Cytochrome P450 (CYP)-related drugs).
Some respondents recommended a clear statement on the principal display panel such as: “Contains cannabidiol (CBD). Consult a healthcare practitioner before use if taking medications.”
Some respondents expressed support for child-resistant packaging, though others noted it may be difficult for users over 65 years old.
Health care practitioners and health care associations
Most respondents were supportive of requiring a warning statement that clearly states the product contains CBD, ideally on the principal display panel. They noted that warnings should be consistent, evidence-based and easy to understand.
They also suggested a standardized warning such as: “Contains cannabidiol (CBD). Consult a healthcare professional before use if taking other medications.”
While there was support for transparency, some respondents cautioned against excessive or fear-inducing warnings that could stigmatize CBD products. They emphasized the need for balanced, proportionate labelling that informs without alarming.
Other considerations
Respondents also noted that:
- labels should inform consumers about potential drug interactions, especially with medications metabolized by the CYP450 enzyme system
- clear labelling helps prevent accidental misuse, especially among vulnerable populations (for example: those over 65 years old, pregnant individuals, people taking multiple medications)
- there may be a risk of confusion between similar-looking NHPs, for example Vitamin D versus Vitamin D plus CBD
- peel-back labels are difficult for some users, for example those over 65 years old
Provincial governments
Respondents were supportive of a prominent CBD warning on NHPCCs.
They also recommended:
- warnings to highlight potential interactions with medications (for example: anticoagulants, antidepressants) and to advise consumers to consult a healthcare professional before use, especially if they are on other medications or have underlying health conditions
- warnings such as “keep out of reach of children”
- child-resistant and tamper-evident packaging and that products should not be appealing to youth
- additional information on expected effects and duration of CBD, safe usage, potential side effects and risks for vulnerable populations (for example: pregnant individuals, youth)
- aligning labelling with existing NHPR and Cannabis Act standards to avoid consumer confusion and regulatory inconsistency
Other considerations
One respondent recommended that labels should inform consumers about the risks of travelling internationally with CBD products, as CBD is still illegal in many jurisdictions.
Academia
Respondents were supportive of mandatory warnings, since clear warnings can help prevent unintentional use and support informed decision-making. They noted that labels should clearly state that the product contains CBD on the principal display panel.
They also recommended that warnings should address risks to:
- children and youth
- pregnant and breastfeeding individuals
- people with allergies to cannabis
- those using other substances or medications
They noted that research supports that cannabis health warnings improve consumer awareness of health risks.
Respondents noted that labels should include information on ingredient interactions and contraindications, especially for vulnerable populations.
Individuals
Most respondents were supportive of mandatory standard warnings similar to those used for other NHPs.
They noted that warnings can inform patients on the potential adverse effects or drug interactions and the risks for vulnerable populations (for example: children, pregnant individuals).
Some respondents recommended:
- using a warning such as: “Contains cannabidiol (CBD). Consult a healthcare provider if taking other medications.”
- using statements discouraging use for unproven purposes (for example: reducing opioid use)
- using a CBD symbol (similar to the THC symbol) instead of a full warning, noting that excessive warnings may stigmatize CBD or confuse consumers
Some noted that warnings are unnecessary if CBD is listed as an ingredient and that many NHPs can interact with medications but do not require warnings on the principal display panel.
Other considerations
Many respondents supported clearly stating the amount of CBD contained in the product on the principal display panel. They also suggested that labels should include:
- CBD dosage
- list of ingredients
- purpose or health use
- Health Canada endorsement for claims
Respondents also provided suggestions on packaging, indicating support for:
- child-resistant and tamper-proof packaging
- avoiding youth-appealing designs (for example: glossy finishes, health-themed imagery)
- package inserts or QR codes linking to educational resources
Advocacy organizations
Advocacy organizations supported clear labelling and including a CBD warning statement.
Clinical trials and evidence requirements
Respondents provided comments on whether NHPCCs should have the same requirements as other clinical trials involving NHPs and whether sponsors should be required to have a cannabis research licence under the Cannabis Regulations.
Industry associations
Regulatory and financial burden
Respondents raised considerations around regulatory and financial burden, noting that:
- small and medium-sized producers struggle to meet Good Clinical Practice standards
- there is a lack of public funding for cannabis-related NHP research
- there are high costs and complexities in conducting clinical trials
- regulatory uncertainty and ingredient sourcing issues hinder clinical trial initiation
Many respondents indicated that:
- the clinical trial requirements mentioned in the discussion paper were modeled after pharmaceutical standards and would not be suitable for NHPs
- phase III trials may delay a product entering the market until 2035, and that such trials are excessive for low-risk substances like CBD
- full-scale trials should be reserved for high-risk or novel indications
- the regulatory requirements should be simplified, such as removing the requirement for cannabis research licences and import permits for low-risk NHPCCs
Some respondents indicated that:
- they do not consider CBD “novel” and highlighted its traditional use, especially by Indigenous communities
- the current classification as a controlled substance complicates research and market access
- consideration should be given to research on whole-plant formulations, not just isolates
- clinical trials are important to provide pharmacists and healthcare providers with robust, evidence-based guidance to safely advise patients
Other considerations
Some respondents expressed interest in a CBD monograph outlining acceptable claims, dosages, formats and safety warnings to streamline product licensing and reduce redundant trials.
Some respondents also suggested accepting alternative evidence, such as observational studies and practitioner reports and that existing literature and systematic reviews should be allowed to support low-risk claims.
Individual companies
Regulatory and financial burden
Respondents raised considerations about regulatory and financial burden, noting that:
- phase III clinical trials are expensive and create a financial barrier, especially for small and medium-sized enterprises
- there is lack of return on investment due to limited intellectual property protection
- dual regulation under the Cannabis Act and Food and Drugs Act (FDA) creates confusion and delays
- requirements for cannabis research licenses and import/export permits add unnecessary burden
- there is a lack of clear guidance on acceptable evidence types (for example: observational studies, in vitro data)
Operational and systemic challenges
Respondents raised operational and systemic challenges, including:
- difficulty sourcing GMP-grade CBD
- delays due to ethics board approvals and institutional inconsistencies
- shipping and re-export issues for investigational products
- lack of consistent dosing guidelines or product formats
- most existing studies focus on high-dose pharmaceutical CBD, not low-dose wellness applications
- cannabis stigma persists in academic and medical settings; universities and ethics boards are hesitant to approve CBD-related trials
Recommendations
Respondents offered recommendations related to research and evidence standards, including:
- developing a CBD monograph to define acceptable claims, dosages, formats and safety warnings using international data and post-market surveillance
- accepting alternative evidence such as existing literature, real-world data, traditional use and international data (for example: from the European Union, United Kingdom, Australia) as part of the evidence base for lower-risk claims
- requiring full clinical trials for high-risk or novel claims only
- simplifying regulatory requirements by:
- creating a simplified clinical trial framework for NHPCCs
- exempting low-risk NHPCCs from certain pharmaceutical-grade requirements
- establishing a single-window system for non-pharmaceutical sponsors
Respondents also recommended supporting innovation and research by:
- providing regulatory exclusivity for sponsors who invest in clinical trials
- offering government or industry-funded research support for small and medium-sized enterprises
- encouraging post-market surveillance and real-world evidence collection
Healthcare practitioners and healthcare associations
Regulatory and financial burden
Respondents raised concerns about regulatory and financial burden, noting:
- CBD is still regulated under the Cannabis Act, even for low-risk, non-intoxicating uses
- dual compliance with the Cannabis Act and FDA creates administrative burden and delays
- lack of a harmonized, proportionate framework discourages research
- high costs of clinical trials, especially for smaller firms and academic institutions
- lack of public funding for cannabis-related NHP research
Operational and systemic challenges
Respondents raised operational and systemic challenges, including:
- difficulty sourcing standardized, pharmaceutical-grade CBD that meets NHP standards
- that most products available are GPP compliant, not GMP compliant, which limits trial quality
- stigma around cannabis affects participant recruitment and ethics board approvals
- hesitation among conservative individuals or people with complex health needs
- lack of clarity on what constitutes sufficient evidence (for example: real-world data, observational studies, randomized control trials)
Some respondents also noted concerns about the increase in low-quality evidence and emphasized the need for more high-quality, peer-reviewed studies.
Recommendations
Respondents offered recommendations related to research and evidence standards, including:
- maintaining GMP standards to ensure trial integrity
- increasing funding for cannabis research to generate robust evidence
- developing a clear, tiered evidence framework that defines acceptable evidence types based on product risk and intended use and allows for real-world data and observational studies for low-risk claims
- generating additional clinical evidence would support pharmacist involvement in NHPCC sales and oversight
- encouraging innovation through proportionate regulation by not applying pharmaceutical-grade clinical trial requirements to low-risk NHPCCs; having a tiered, risk-based approach would support innovation while ensuring safety
Provincial governments
Respondents indicated that they are aware of the challenges associated with conducting clinical trials for CBD products, including regulatory complexities and funding limitations.
Recommendations
Respondents suggested that Health Canada provide funding support or incentives for research focused on CBD's effects, particularly in vulnerable populations.
Individuals
Regulatory and financial burden
Respondents raised concerns about regulatory and financial burden, noting that:
- requiring a cannabis research licence would be excessive for non-intoxicating, natural products like CBD
- the current licensing frameworks are designed for pharmaceuticals, not NHPs
- regulatory agencies and ethics boards often lack understanding of cannabinoids, creating delays and confusion
- clinical trials are financially out of reach for small and medium-sized producers
- government funding is needed to support trials and reduce barriers to innovation
- there is already substantial scientific and anecdotal evidence supporting CBD’s efficacy for conditions like anxiety, pain and inflammation; requiring new, company-specific trials would be redundant
- Health Canada should accept alternative evidence, such as observational data and practitioner reports
Other considerations
Some respondents also expressed:
- concerns that most research focuses only on isolates, ignoring the synergistic effects of whole-plant formulations
- support for allowing multi-ingredient combinations (for example: CBD plus melatonin or L-theanine), if supported by evidence
- opposition to mandatory animal testing
- preference for in vitro and in silico (computer simulation) methods using human cells
- support for ethical clinical trials in animals only if non-harmful and relevant
Recommendations
Respondents offered recommendations related to research and evidence standards, including:
- removing cannabis licensing requirements for CBD-only NHPCCs trials using certified ingredients
- funding clinical trials through public programs to support innovation and accessibility
- accepting international and real-world evidence to support claims
- clarifying regulatory expectations for isolate versus full-spectrum products
- recognizing traditional and whole-plant use in regulatory frameworks
Academia
Respondents offered recommendations, including:
- streamlining oversight by improving Health Canada’s review efficiency and expertise
- allowing access to Investigational Status Assessment pathways for NHPs to reduce unnecessary regulatory burden
Advocacy organizations
One submission advocated for cruelty-free testing on animals for NHPCCs and recommended only allowing clinical trials if they do not harm animals.
Place of sale and retail considerations
Respondents provided their views on where NHPCCs should be sold and how to improve consumer safety and prevent misuse.
Industry associations
Most respondents were supportive of allowing NHPCCs to be sold in the same locations as other NHPs, noting that:
- pharmacies provide suitable clinical oversight, public health support, and trusted access to health products
- health food stores and wellness retailers are appropriate locations and consistent with how other NHPs are sold
- online sales support broad accessibility and consumer convenience
Some respondents supported sale of NHPCCs in grocery and convenience stores, especially for low-dose, low-risk products.
Some respondents also raised the possibility of a risk-based sales model based on potency where low-dose products (for example: products containing recommended CBD doses of less than 200 mg per day) could be available over-the-counter in typical NHP retail settings, whereas higher-dose products (for example: products containing recommended CBD doses of equal to or more than 200 mg per day) could be sold behind the pharmacy counter and require pharmacist consultation.
Respondents generally agreed that restricting NHPCCs to cannabis retailers would undermine such products being classified as NHPs. This approach would limit consumer access and trust and would be contradictory to the non-intoxicating nature and safety profile of CBD.
Respondents suggested that having clear labelling, dosage guidelines and staff training are sufficient safeguards. Some were also supportive of additional safeguards, including age restriction (for example: 18 years of age and older), pack-size limits and pharmacist counselling.
Individual companies
Most respondents were supportive of allowing NHPCCs to be sold in the same locations as other NHPs, including pharmacies, health food stores, online platforms, grocery stores and specialty stores.
Respondents were not supportive of restricting sales to cannabis retail stores or pharmacies only. They noted sales in cannabis stores may negatively impact consumer accessibility, especially in rural or underserved areas. Sales in cannabis stores was seen as restrictive and risked stifling competition and could lead to higher prices.
Several respondents recommended a tiered approach:
- low-dose products (for example: between 25 and 50 mg per day) could be available for general sale in retail settings
- moderate to high-dose products (for example: more than 50 and up to 200 mg per day) could be sold behind the counter in pharmacies or with healthcare provider involvement
- combination products or those with high risk could require pharmacist consultation or healthcare screening during an appointment with a practitioner
Many respondents commented that label warnings and point-of-sale disclosures are sufficient for safety and that over-regulation could reduce affordability and consumer choice.
Some respondents preferred a pharmacy-only retail model, noting that pharmacists can provide clinical guidance, advise on drug interactions and support safe use. Further, it was noted that pharmacies offer secure storage, inventory control and traceability.
Other considerations
Some respondents recommended:
- age restrictions (for example: 18 years of age and older)
- child-resistant packaging
- maximum daily dose limits (for example: between 70 and 200 mg per day)
- strict THC limits (for example: no more than 1 mg per package or 0.3%)
- exclusion of high-risk formats (for example: vapes, candy-like edibles) to improve consumer safety and prevent misuse of NHPCCs
Healthcare practitioners and healthcare associations
Respondents were supportive of sales through pharmacies as pharmacists can:
- provide oversight for safety
- assess drug interactions and provide patient counselling
- provide controlled environments for storage, inventory and traceability
Some respondents raised concerns that selling NHPCCs outside of pharmacies may undermine their perceived risk and lead to misuse, while others cautioned that pharmacy-only models could limit access in rural or underserved areas.
Some respondents recommended a risk-based tiered model allowing low-risk products to be sold with fewer restrictions and higher-risk products (for example: high-dose CBD, products with new delivery systems) requiring pharmacist oversight.
Some respondents supported additional access points, such as health food stores, online platforms and naturopathic doctor offices.
Other considerations
Respondents emphasized the need for clear labeling, dosing transparency and evidence-backed claims to prevent the risk of misuse and optimize consumer safety.
They also suggested considering age restrictions (for example: 18 years of age and older) and pack-size limits (for example: maximum of 30-day supply).
Some respondents indicated that they oppose selling THC-containing products in pharmacies, citing misuse concerns, noting that CBD-only products are generally more accepted.
Provincial governments
Respondents were supportive of exclusive or initial sales through pharmacies, with products stored behind the counter.
They indicated a preference for involving pharmacist supervision in sales to allow for counselling on drug interactions, dosing and contraindications. They further suggested that this would help protect vulnerable populations and prevent misuse, especially among youth.
Respondents indicated support for minimum age requirements (for example: 18 years of age and older) to prevent youth access.
One respondent noted that provincial cannabis retailers are well-positioned to distribute NHPCCs due to:
- their existing regulatory compliance
- the potential to expand training to include NHPCC-specific education
- their role in supporting public health and safety
One respondent suggested a phased rollout, beginning with pharmacy-only sales, allowing time to address any unforeseen issues before expanding to broader retail sale. They raised concerns that self-selection and self-serve access (for example: in health food stores or online) may lead to impulse purchases and uninformed use. They also suggested that online sales should include mechanisms to verify consumer understanding of possible risks of using the product.
Academia
Respondents recommended a balanced, risk-based approach for place of sale.
They suggested that low-strength CBD products could be sold in locations consistent with other NHPs (for example: pharmacies, health food stores), provided there is clear labelling of contraindications, warnings, drug interaction risks and age restrictions to prevent youth access.
They suggested that high-strength or high-risk products should be restricted to pharmacies, possibly sold behind the counter, and accompanied by pharmacist counseling on dosage, adverse effects and safe use.
Some respondents recommended pharmacy-only sales due to:
- gaps in evidence on CBD safety in certain populations
- the potential for drug interactions
- the need for professional guidance to ensure appropriate product selection and use
Respondents expressed concerns about normalization, given that high availability and low restrictions may lead to increased experimentation, especially among youth. They suggested that restricting sales to pharmacies would help balance access with public health protection.
Advocacy organizations
We received 1 submission, which was supportive of pharmacy-only and behind-the-counter sales to facilitate conversations between consumers and patients with pharmacists.
Individuals
Most respondents were supportive of allowing NHPCCs to be sold in the same locations as other NHPs, including pharmacies, health food stores, online platforms, grocery and convenience stores and wellness boutiques, as well as in cannabis retail stores.
Many respondents opposed limiting sales to pharmacies or behind-the-counter models, arguing it would reduce accessibility, contradict the NHP classification and would be inconsistent with how higher-risk products (for example: nicotine) are sold.
Some respondents suggested a risk-based model that would place low-dose CBD for general sale and high-dose CBD behind the counter or with pharmacist guidance.
Some respondents advocated for home cultivation and dispensary access.
Other considerations
Respondents had mixed views on age restrictions. Some supported age limits (for example: 15 years of age and older, 18 years of age and older) for higher-dose products. Others mentioned that age restrictions are unnecessary and could do more harm than good.
Some respondents supported:
- clear, consistent labelling
- dosage guidelines
- warnings about drug interactions
- educational materials (for example: pamphlets, QR codes that link to supplementary material)
Some respondents recommended certified cannabis educators and public awareness campaigns.
Advertising and promotion
Respondents provided their views on the proposal to maintain advertising and promotion for NHPCCs under the FDA, as well as other considerations.
Industry associations
Most respondents agreed with the proposal outlined in the discussion paper that advertising rules for NHPCCs should follow the same standards as other NHPs under the FDA and the NHPR. This includes:
- truthful, evidence-based claims
- prohibition of misleading or exaggerated benefits
- Health Canada-approved therapeutic claims only
Respondents cautioned against applying Cannabis Act advertising restrictions to non-intoxicating CBD health products. They noted that such restrictions could stigmatize CBD, hinder consumer education and limit industry growth.
Many respondents were in favour of permitting lifestyle positioning and wellness messaging, as long as it aligns with the product licence and is not misleading.
A minority of respondents suggested stricter controls to prevent consumer misinformation.
Other considerations
Respondents raised other considerations, including:
- requiring clear labeling
- requiring dosage guidelines
- factual product information
- allowing testimonials and educational campaigns that comply with NHPR
- monitoring celebrity endorsements to ensure that the endorsements do not mislead or overstate product benefits
Individual companies
Most respondents agreed with the proposal that NHPCCs follow the same advertising and promotion rules as other NHPs under the FDA and NHPR.
Some respondents supported stricter controls, especially for products making therapeutic or medical claims. Others warned against overregulation, citing the negative impact of cannabis advertising restrictions on industry growth and consumer awareness.
Respondents offered recommendations, including:
- allowing claims supported by scientific evidence, similar to other NHPs (for example: melatonin, omega-3s) and avoid applying Cannabis Act-style restrictions to non-intoxicating CBD products
- encouraging educational content (for example: blogs, videos, brochures) to inform consumers about CBD’s uses, dosage and safety and promote pharmacy-based education and healthcare provider guidance
- clarifying rules for e-commerce, search engine optimization, social media and online advertising and ensuring digital marketing is responsible and accurate
- avoiding overly restrictive packaging as current cannabis packaging rules are seen as too strict for wellness products
- allowing appealing, informative packaging with clear branding and usage instructions
- prohibiting youth-targeted marketing and include age-appropriate messaging and risk disclosures
- encouraging the voluntary use of advertising preclearance agencies and emphasize enforcement of non-compliance through existing mechanisms
Health care practitioners and health care associations
Respondents supported applying existing NHP advertising rules rather than the Cannabis Actand emphasized the importance of truthful, evidence-based, Health Canada-approved health claims only. There was consensus amongst respondents that advertising should not appeal to minors.
A few respondents advocated for stricter advertising rules, similar to those for prescription drugs, to prevent misleading claims and unsupervised use. Others emphasized “education over hype”, supporting factual, transparent communication without overregulation.
Respondents offered recommendations, including:
- banning lifestyle imagery, cartoons or influencers, flavour descriptors, loyalty programs or price promotions
- advertising that clearly states that the product is an NHP not a recreational or prescription cannabis product
- messaging that includes balanced information on benefits and risks, including drug interactions, contraindications and warnings for vulnerable populations (for example: pregnant individuals, youth)
- support for in-pharmacy informational materials and professional guidance as pharmacists are key players supporting responsible promotion and consumer education
- monitoring and enforcing digital and social media promotions due to concerns about misinformation online, especially from influencers or unregulated sources
Provincial governments
1 respondent noted that NHPCC advertising should follow the FDA and the NHPR, and enforcement actions should be taken in cases of non-compliance.
Other respondents urged Health Canada to align advertising rules for NHPCCs with those for CBD products under the Cannabis Act. They noted that inconsistent rules could lead to consumer confusion and an uneven regulatory environment.
Respondents offered recommendations, including:
- advertising that avoids exaggerated or unsubstantiated health claims (for example: for migraines or arthritis), includes known side effects (for example: drowsiness, nausea, drug interactions) and communicates what is known and unknown about CBD’s long-term effects
- advertising that does not target adolescents or vulnerable groups and avoidance of youth-oriented branding, celebrity endorsements and influencer marketing
- monitoring digital platforms for compliance
- emphasizing transparent, educational advertising to support informed consumer choice and public trust
Academia
Respondents were supportive of aligning NHPCC advertising rules with the FDA and existing NHP advertising standards to ensure regulatory consistency and avoid applying Cannabis Act-style restrictions unless necessary for public health protection.
Respondents were also supportive of prohibiting advertising that appeals to children or youth. They raised concerns that the normalization of cannabis products through less restrictive advertising could lead to increased experimentation and demand among youth.
Respondents offered recommendations, including:
- monitoring for youth-oriented branding and restricting influencer marketing and lifestyle imagery
- prohibiting advertising of unsubstantiated health claims, especially for conditions like pain, anxiety or sleep disorders, or false or misleading claims that may lead consumers to choose CBD over more effective treatments
- advertising that includes disclosures of known side effects and limitations of use
- emphasizing transparency to protect vulnerable populations and support informed decision-making
Advocacy organizations
No comments received.
Individuals
Respondents were supportive of factual, educational advertising over sensationalism.
They suggested that Health Canada should allow licence holders to share transparent data and evidence-based information and that celebrity endorsements and misleading promotions should be monitored and regulated.
There was general agreement that advertisements should not target minors or use imagery appealing to youth.
Some respondents were supportive of Cannabis Act-style restrictions to prevent youth appeal. Others suggested online-only advertising or no advertising at all.
Respondents offered recommendations, including:
- providing regulatory clarity and consistency with clear guidance on when NHPCCs must comply with the Cannabis Act versus the FDA and NHPR
- supporting joint oversight and enforcement; advertising compliance that is a shared responsibility between the government and producers
- providing a public reporting mechanism for misleading or non-compliant promotions
Post-market surveillance and pharmacovigilance
Respondents provided their views on the proposal that Health Canada use the same post-market safety monitoring approach for NHPCCs that is in place for other similar risk NHPs.
Industry associations
Respondents broadly agreed that NHPCCs should follow existing pharmacovigilance requirements for NHPs. They noted that the current post-market vigilance system is seen as robust and sufficient and there is no justification for additional monitoring for NHPCCs unless new evidence emerges.
They emphasized:
- mandatory adverse reaction reporting to Health Canada’s Canada Vigilance program
- use of existing consumer reporting systems
- active monitoring by manufacturers
- prompt reporting of serious adverse events
They also noted that pharmacists should be designated with reporting responsibilities and permitted to do bulk uploads of reports to relevant systems.
Other considerations
Many respondents endorsed randomized product testing and transparent quality reporting.
Many also suggested that pharmacovigilance systems should account for the recognition of the differences between isolates and full-spectrum extracts.
Individual companies
Respondents were supportive of a risk-based, proportionate framework, given that they view CBD as low-risk, with a well-documented safety profile.
They supported the proposal to align vigilance requirements with existing NHP requirements. They indicated that over-regulation could stifle innovation, especially for small and mid-sized businesses.
Many respondents supported mandatory reporting of serious adverse events, but not for minor or expected effects (for example: drowsiness). Suggestions included:
- a tiered reporting system
- clear guidance on what constitutes a reportable event
- annual summary reports by authorization holders
- the use of existing healthcare infrastructure for reporting
Some respondents suggested integrating NHPCCs into existing drug scheduling and pharmacy frameworks.
Other considerations
Some proposals suggested enhancing surveillance and transparency by including:
- digital tools (for example: mobile apps, QR codes) for consumer and healthcare professional reporting
- active surveillance for high-risk populations (for example: those over 65 years old, pregnant individuals)
- public access to aggregated safety data to build trust
- periodic product testing and real-world use studies
- a centralized federal database for adverse events
There were also suggestions that Canada should align with global standards (for example: the United States Food and Drug Administration, European Food Safety Authority) to avoid trade barriers.
Some respondents recommended that Health Canada form a dedicated working group to review safety data annually on NHPCC products.
Healthcare practitioners and healthcare associations
Respondents did not provide comments on the proposed pharmacovigilance framework, but they highlighted that Health Canada’s current pharmacovigilance specialists under the Cannabis Act should be involved in NHPCC oversight. They noted that these experts have experience with causality assessments and identifying drug interactions involving CBD and THC.
Respondents offered recommendations, including:
- mandatory adverse event reporting to reinforce and tailor reporting requirements; manufacturers and importers should actively monitor and report serious/unexpected adverse reactions, especially in vulnerable populations (for example: those over 65 years old, children, pregnant individuals)
- empower and encourage pharmacists and healthcare providers to report adverse events, including streamlined reporting tools, integration into pharmacy software or electronic health records and education and awareness campaigns
- establish a publicly accessible database for adverse event reports to support safety signal detection, trend analysis and public trust
- monitor real-world use by tracking off-label use and polypharmacy risks
- collaborate with academic institutions, pharmacies and provincial monitoring programs for research and data collection
- monitor for contamination, mislabeling and inconsistent potency and implement batch-level traceability and recall mechanisms
- commit to periodic re-evaluation as new safety data emerges
Other considerations
Respondents supported:
- randomized product testing
- transparent quality reporting
- annual safety updates
- periodic safety assessments
Some respondents indicated that mandatory reporting by both consumers and professionals is critical. Some suggested leaving oversight to existing pharmacy protocols.
Provincial governments
Respondents were supportive of maintaining adverse reaction monitoring and reporting under the current NHPR. They encouraged Health Canada to enhance surveillance tools by using real-world data, data mining techniques and by improving safety signal detection for adverse events.
Other considerations
One respondent recommended a national public education campaign to:
- clarify what CBD is and is not
- promote responsible use and adherence to labelled doses
- emphasize that CBD is not risk-free
- encourage consultation with healthcare professionals for individuals with serious health conditions
Academia
Respondents were supportive of pharmacovigilance and post-market surveillance, including monitoring for product selection and usage errors. They suggested using the Canadian Medication Incident Reporting and Prevention System to capture such incidents and emphasized that many of these errors are preventable if contributing factors are identified early.
One respondent proposed collecting sociodemographic information from individuals reporting adverse events to help address data gaps in safety and efficacy for understudied or high-risk populations, including:
- those over 65 years old
- people with liver damage
- ethnic and Indigenous populations
- pregnant and breastfeeding individuals
- children and young adults (especially those between 18 and 25 years old)
- members of the 2SLGBTQIA+ community
- people with mental or psychiatric conditions
Advocacy organizations
No comments received.
Individuals
Respondents were generally supportive of treating NHPCCs like other similar-risk NHPs. Some believe no additional vigilance is needed beyond what is already in place for high-risk NHPs.
Respondents agreed that post-market surveillance is essential. They supported mandatory adverse event reporting by companies and suggested that companies should submit annual adverse event summaries for the first 2-3 years of new products.
Other considerations
Respondents noted the need for easy and transparent reporting mechanisms for consumers. They proposed consumer reporting and engagement with accessible consumer feedback tools, such as a feedback portal or a “Rate This Weed” website for anonymous reviews.
They supported randomized product testing, transparent quality reporting and accurate dosage labeling to ensure product quality and label accuracy.
They recommended that pharmacovigilance should consider differences between isolates and full-spectrum extracts and that Health Canada should be proactive in identifying safety issues.
Additional considerations
This section includes a summary of additional considerations, classified by subject.
Regulatory streamlining and public health
Some respondents advocated for rapid authorization of NHPCCs without requiring licensing under the Cannabis Act or Industrial Hemp Regulations, noting that this would:
- improve public health by displacing illicit, unregulated CBD products
- provide economic and industry benefits
- align Canada with international best practices
- leverage the hemp industry’s 27-year safety record
Compliance and enforcement
Respondents expressed support for:
- Health Canada’s current enforcement approach, including stop-sale orders, licence suspensions and voluntary recalls
- stronger oversight of non-compliant NHP companies and clear enforcement mechanisms for advertising and product claims
- alignment of record-keeping requirements with existing NHPR due to the low diversion risk of CBD products
- monitoring and evaluation frameworks to track adverse reactions and ensure ongoing compliance
Import and export
Some respondents indicated that the import/export permits currently required under the Cannabis Act are overly restrictive.
Some offered recommendations, including:
- allowing export of NHPCCs without a permit
- updating Canada’s interpretation of United Nations treaties to reflect WHO guidance that CBD with up to 0.2% THC is not a controlled substance
- aligning with international standards (for example: United States Pharmacopeia monograph) to support global trade and competitiveness
Product standards and THC limits
Some industry associations and individual companies indicated that they disagree with the proposed 10 parts per million THC limit, noting that it is restrictive and potentially inconsistent with international limits for other types of CBD products and raw materials.
Some respondents indicated that they support full-spectrum CBD products and noted the “entourage effect”, with some proposing to allow up to 5% THC of total cannabinoids.
Economic and industry considerations
Some respondents expressed support for:
- Canadian-grown hemp supply chains
- fair pricing and reduced red tape
- tax revenue generation and job creation through a regulated CBD market
Product scope and innovation
Some respondents expressed support for:
- full-spectrum and multi-ingredient formulations of NHPCCs
- topicals and cosmetics with higher THC limits (for example: 50 mg per g)
- inclusion of other “minor” cannabinoids (for example: CBG, CBC)
- recognition of traditional and real-world evidence in product approvals
Education and public health
Healthcare respondents noted the importance of:
- public education campaigns about CBD safety and proper use and potential risks
- healthcare provider training on CBD interactions and dosing
Conclusion
The feedback received through this consultation reflects that a broad range of stakeholders have a strong interest in shaping a regulatory framework for NHPCCs that is evidence-based, proportionate and responsive to both public health priorities and industry realities.
Across all stakeholder groups there is support for a regulatory framework that ensures product safety, quality and transparency, while also enabling innovation and consumer access.
Respondents emphasized the importance of:
- maintaining a risk-based approach aligned with existing NHP regulations
- avoiding duplicative or overly restrictive requirements, particularly those modeled after the Cannabis Act
- ensuring robust post-market surveillance, including mandatory adverse event reporting and consumer-friendly reporting tools
- supporting public education and healthcare provider training to promote safe and informed use
- encouraging research and innovation, including the use of real-world evidence and traditional knowledge
- clarifying product standards, including THC limits, labelling and packaging requirements
- facilitating access through appropriate retail channels and minimizing unnecessary regulatory burden
Veterinary drugs containing cannabidiol
Context and overview of the consultation process
On March 7, 2025, Health Canada published an exploratory discussion paper to gather feedback from stakeholders and the public regarding the potential pathway for the authorization of health products containing cannabidiol (CBD) – referred to as veterinary drugs containing CBD (VDCCs) for animals. This builds on:
- Health Canada’s 2019 consultation about the potential market for non-prescription health products containing cannabis that would not require practitioner oversight
- 2020-22 efforts of the Science Advisory Committee (SAC) in providing independent scientific and clinical advice (including final report) to support Health Canada’s consideration of appropriate safety, efficacy and quality standards for health products containing cannabis for use without practitioner oversight
- Recommendations G, H, I of the SAC report reflected that there was only sufficient safety evidence for CBD use in dogs at doses between 0.2-2mg/kg orally twice daily, used for the treatment of pain associated with osteoarthritis, and based on a confirmed diagnosis of osteoarthritis from a veterinarian. They also included that until more safety and efficacy information is available, pet-owners should consult a veterinarian prior to administering CBD to their pets
- Health Canada’s 2022 Notice to stakeholders consultation that asked for input to support the development of a potential regulatory pathway that would permit CBD as a medicinal ingredient in certain health products for human and animal use, regulated under the Food and Drugs Act (FDA), which would not require a prescription
The 2025 discussion paper focused on key elements of a proposed pathway for non-prescription VDCCs for animal use:
- pre-market safety, efficacy and quality
- establishment licensing, good manufacturing practices (GMP) and controls
- packaging and labelling
- experimental studies/research
- place of sale, advertising and promotion
- post-market safety monitoring
- compliance and enforcement
The discussion paper also noted the regulatory considerations in evaluating whether a drug would be better sold as a prescription or non-prescription product to protect the health and safety of Canadian consumers and of animals, and safety of the food supply.
Stakeholders were asked to respond to consultation feedback questions, and to share any scientific or clinical evidence or literature studies they may have on the safety, efficacy and quality of cannabis (including CBD) for use in animals.
Feedback was received via an online submission form as well as by direct email. Health Canada received 135 sets of feedback in total (across the human and animal contexts), with 90 sets specific to VDCCs for animal use. Of the 90 sets, the majority were from healthcare practitioners, industry and their associations, followed by other government bodies, academia and the general public. This is an addendum summary for the veterinary drug context.
Summary of what we heard
The following is a summary of the feedback related to VDCCs for animal use, including the level of stakeholder support. Stakeholders provided input on the possible development of a pathway under the Food and Drug Regulations (FDR) for VDCCs as non-prescription drugs.
Pre-market context
There was a diverse range of feedback with general support for a streamlined approach as opposed to the full FDR Division 8 submission requirements (safety, efficacy, quality) for seeking market authorization. Although there was support for considering VDCCs as non-prescription drugs, there was also some feedback suggesting that VDCCs should be considered as veterinary health products (VHPs) and with a broader range of health claims permitted, and a few comments that all products containing cannabis should remain under the Cannabis Act (CA) and Cannabis Regulations (CR). Some healthcare professionals stated that VDCCs should require a prescription.
There were additional ideas provided, such as: creating a “Pre-approved ingredient Monograph” and not limiting the scope to CBD, regulating CBD in line with the proposal underway in the U.S. (as a subset of feed/food additives), considering a “modified veterinary DIN application” (FDR Division 1) specific to low risk cannabinoids, having a dedicated review committee, developing a tiered risk-based model, starting with a pilot phase with limited scope, and enhancing post-market surveillance in exchange for streamlined pre-market requirements.
Manufacturing and controls
The majority of feedback agreed with retaining the Cannabis Drug Licence (CDL) for processors (i.e. CBD “input”) and streamlining or not duplicating physical and personnel security controls. However, for GMP and Good Production Practices (GPP) there was a range of feedback – some supported the need for both (e.g. GPP for raw material/CBD, GMP for finished health product), some suggested neither and instead apply simplified requirements like Part 3-GMP in the Natural Health Products Regulations (NHPR), and some to retain status quo with the framework under the CA and CR. There was general support for requiring certificates of analysis for CBD used in VDCCs to help confirm CBD and delta-9-tetracannabinol (THC) levels and ensure quality and consistency.
Packaging and labelling
There was majority support for a CBD content statement (not a warning) on labels (not on the main panel), while a few suggested a 1–2-year time period for a warning statement until there is more familiarity. Some noted the importance of labelling any contra-indications, and one shared that labels should inform consumers about the risks of travelling internationally with CBD products, as CBD is still illegal in many jurisdictions.
Experimental studies and research
There was general support for a streamlined approach as opposed to the current 2-step model (an experimental studies certificate and a cannabis research licence). There were some comments about research being hindered by inconsistent research frameworks, lack of funding, limited patentability, and limited access to standardized GMP-compliant CBD to support drug development.
Place of sale, advertising and promotion
There was no consensus and a diverse range of comments were submitted. Many stakeholders said that VDCCs should be available at retail (such as department stores or pet stores), at front-of-counter at veterinary clinics, and online. One suggested that if any concerns arise, consumers should consult their veterinarian. In opposition, many healthcare professionals/pharmacists suggested using pharmacies for sale and distribution stating that they are well-established, and others stated that VDCCs should only be available via a veterinarian or pharmacy. Other ideas were also provided, such as a staggered approach (e.g. start with clinics, then to retail channels after some years), or that CBD for pets (non-food-producing animals only) could be available at retail, and another suggested a potency-dependent model for what is available behind the counter versus retail. There was general support for maintaining advertising and promotion requirements for VDCCs under the FDA.
Post-market context
There was general support for maintaining the same post-market safety monitoring requirements and obligations as other veterinary drugs under the FDA and FDR, as well as for the risk-based approach to compliance and enforcement.
Additional considerations
Additional considerations were also submitted by stakeholders, some that were within the scope of the paper and others that were not. Examples include:
- 10ppm THC limit: comments that this is not aligned with other regulatory or standard setting bodies (e.g. USP recommends 99.8% purity/0.1% THC – 1000ppm), and that the SAC had recommended 300 x higher (0.3%).
- Scope: comments that the framework should not permit synthetics/isolates (only permit pure plant extracts) and include other non-intoxicating cannabinoids that hold therapeutic potential – with a push for full-spectrum cannabinoid/whole-plant.
- Funding: recommendation for a “state grower” model that is not for profit and free for the public.
- Studies and research: suggestions for enabling research, such as a product registry to encourage ongoing data collection and real-world evidence, a ban or prohibition on synthetic cannabinoids and terpene additives, government or industry-funded research initiatives to help small businesses generate evidence, and that Health Canada should develop standardized dosing guidelines and ethical study protocols for CBD use in animals.
- Human and animal pathways: comment to decouple VDCCs for animals from NHPCCs for humans, stating that “the use cases, safety considerations, and commercial needs are distinct enough to merit separate frameworks and timelines”.
- Marketing: comments about the need for clear e-commerce and digital marketing rules to ensure consumer access to reliable information.
- Hotline or contact information: comments about a hotline (or centralized digital reporting system) for animal owners, to help obtain safety data over time.
- Illicit market: comments that there are ongoing concerns with illicit market and illegal products.
- Environment: reminders about environmental considerations like air quality emissions from facilities, and the need for controls.
- Evidence: stakeholders were asked to share any additional data and references, and some indicated that there is growing evidence, some provided lists of references and studies.
- Animal testing: comment that all animal testing be stopped.